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Levofloxacin | CAS No: 100986-85-4 | GMP-certified suppliers
A medication that treats diverse bacterial infections across respiratory, skin, urinary, ocular, and specialized anthrax, plague, and cystic fibrosis settings in key global markets.
Therapeutic categories
Primary indications
- In oral and intravenous formulations, levofloxacin is indicated in adults for the treatment of various infections caused by susceptible bacteria, including infections of the upper respiratory tract, lower respiratory tract, skin, skin structures, urinary tract, and prostate
- The oral formulation is also indicated in both adults and children 6 months of age and older for the post-exposure management of inhalational anthrax caused by _Bacillus anthracis_ and for the treatment and/or prophylaxis of plague caused by _Yersinia pestis_
- In its ophthalmic formulation, levofloxacin is indicated for the treatment of bacterial conjunctivitis caused by susceptible organisms
Product Snapshot
- Levofloxacin is available as an oral and injectable small‑molecule antibiotic, with additional ophthalmic, otic, and inhalation solutions
- It is used for a broad range of susceptible bacterial infections across respiratory, urinary, skin, and ocular tissues, and for specific post‑exposure indications such as inhalational anthrax and plague, as well as chronic pulmonary Pseudomonas infections in cystic fibrosis
- It is approved in the US, EU, and Canada, with some formulations also designated as investigational
Clinical Overview
Clinically, levofloxacin is used in adults for infections of the upper and lower respiratory tract, skin and skin structures, urinary tract, and prostate when caused by susceptible bacteria. Oral formulations are additionally indicated for post‑exposure prophylaxis of inhalational anthrax and for treatment or prophylaxis of plague in adults and in children six months of age or older. Ophthalmic preparations are used for bacterial conjunctivitis, and an inhalational formulation available in Canada supports management of chronic Pseudomonas aeruginosa pulmonary infection in cystic fibrosis patients aged 18 years or older.
Levofloxacin is bactericidal. It inhibits DNA gyrase and topoisomerase IV, two bacterial type II topoisomerases essential for DNA supercoiling, replication, and chromosome segregation. Drug–enzyme–DNA complex formation blocks DNA replication and cell division, leading to bacterial death. Mutations in topoisomerase targets or changes in efflux can confer resistance, and cross‑resistance may occur among fluoroquinolones.
Absorption after oral administration is generally rapid, and systemic exposure supports once‑ or twice‑daily dosing. The drug is mainly eliminated renally as unchanged substance. As a moderate risk QTc‑prolonging agent, levofloxacin warrants caution in patients with predisposing factors or concomitant QT‑prolonging drugs. Additional safety considerations include potential photosensitivity, tendinopathy, and risks associated with central nervous system effects. Local susceptibility data should guide therapeutic use.
Common usage contexts include systemic tablets and injectables, ophthalmic solutions, and specialized inhalational solutions in certain regions. Notable branded products have varied globally over time.
For API procurement, sourcing should prioritize manufacturers with demonstrated control of stereochemical purity, residual solvent compliance, and robust documentation of impurity profiles, given the structural sensitivity and regulatory expectations for fluoroquinolone APIs.
Identification & chemistry
| Generic name | Levofloxacin |
|---|---|
| Molecule type | Small molecule |
| CAS | 100986-85-4 |
| UNII | RIX4E89Y14 |
| DrugBank ID | DB01137 |
Pharmacology
| Summary | Levofloxacin is a fluoroquinolone that targets bacterial DNA gyrase and topoisomerase IV, disrupting DNA replication and chromosome segregation. Inhibition of these type II topoisomerases produces bactericidal effects across a broad range of aerobic gram‑positive and gram‑negative organisms. Its pharmacodynamic profile includes a long duration of action, potential for QTc prolongation, and susceptibility to resistance driven by target‑site mutations or efflux mechanisms. |
|---|---|
| Mechanism of action | Levofloxacin, like other fluoroquinolone antibiotics, exerts its antimicrobial activity via the inhibition of two key bacterial enzymes: DNA gyrase and topoisomerase IV.Both targets are type II topoisomerases, but have unique functions within the bacterial cell. DNA gyrase is an enzyme found only in bacteria that introduces negative supercoils into DNA during replication - this helps to relieve torsional strain caused by the introduction of positive supercoils during replication, and these negative supercoils are essential for chromosome condensation and the promotion of transcription initiation.It is comprised of four subunits (two A subunits and two B subunits) of which the A subunits appear to be the target of fluoroquinolone antibiotics.Bacterial topoisomerase IV, in addition to contributing to the relaxation of positive supercoils, is essential at the terminal stages of DNA replication and functions to “unlink” newly replicated chromosomes to allow for the completion of cell division. Inhibition of these enzymes by levofloxacin likely occurs via complexation with the topoisomerase enzymes.The end result is a blockade of DNA replication, thus inhibiting cell division and resulting in cell death. |
| Pharmacodynamics | Levofloxacin is bactericidal and exerts its antimicrobial effects via inhibition of bacterial DNA replication.It has a relatively long duration of action in comparison with other antibiotics that allows for once or twice daily dosing. Levofloxacin is associated with QTc-interval prolongation and should be used with caution in patients with other risk factors for prolongation (e.g. hypokalemia, concomitant medications). Levofloxacin has demonstrated _in vitro_ activity against a number of aerobic gram-positive and gram-negative bacteria and may carry some activity against certain species of anaerobic bacteriaand other pathogens such as _Chlamydia_ and _Legionella_.Resistance to levofloxacin may develop, and is generally due to mutations in DNA gyrase or topoisomerase IV, or via alterations to drug efflux.Cross-resistance may occur between levofloxacin and other fluoroquinolones, but is unlikely to develop between levofloxacin and other antibiotic classes (e.g. macrolides) due to significant differences in chemical structure and mechanism of action. As antimicrobial susceptibility patterns are geographically distinct, local antibiograms should be consulted to ensure adequate coverage of relevant pathogens prior to use. |
Targets
| Target | Organism | Actions |
|---|---|---|
| DNA gyrase subunit A | Haemophilus influenzae (strain ATCC 51907 / DSM 11121 / KW20 / Rd) | inhibitor |
| DNA topoisomerase 4 subunit A | Haemophilus influenzae (strain ATCC 51907 / DSM 11121 / KW20 / Rd) | inhibitor |
ADME / PK
| Absorption | Absorption of levofloxacin following oral administration is rapid and essentially complete, with an oral bioavailability of approximately 99%.Due to its nearly complete absorption, the intravenous and oral formulations of levofloxacin may be interchangeable.The T<sub>max</sub> is generally attained 1-2 hours following administration and the C<sub>max</sub> is proportional to the given dose - an intravenous dose of 500mg infused over 60 minutes resulted in a C<sub>max</sub> of 6.2 ± 1.0 µg/mL whereas a 750mg dose infused over 90 minutes resulted in a C<sub>max</sub> of 11.5 ± 4.0 µg/mL.Oral administration with food prolongs the T<sub>max</sub> by approximately 1 hour and slightly decreases the C<sub>max</sub>, but these changes are not likely to be clinically significant. Systemic absorption following oral inhalation is approximately 50% lower than that observed following oral administration. |
|---|---|
| Half-life | The average terminal elimination half-life of levofloxacin is 6-8 hours. |
| Protein binding | Levofloxacin is 24-38% protein-bound in plasma, primarily to albumin. The extent of protein-binding is independent of its plasma concentration. |
| Metabolism | Only 2 metabolites, desmethyl-levofloxacin and levofloxacin-N-oxide, have been identified in humans, neither of which appears to carry any relevant pharmacological activity.Following oral administration, less than 5% of the administered dose was recovered in the urine as these metabolites, indicating very little metabolism of levofloxacin in humans.The specific enzymes responsible for the demethylation and oxidation of levofloxacin have yet to be ascertained. |
| Route of elimination | The majority of administered levofloxacin is excreted unchanged in the urine.Following the administration of a single oral dose of levofloxacin, approximately 87% was eliminated unchanged in the urine within 48 hours and less than 4% was eliminated in the feces within 72 hours. |
| Volume of distribution | Levofloxacin is widely distributed in the body, with an average volume of distribution following oral administration between 1.09-1.26 L/kg (~89-112 L).Concentrations in many tissues and fluids may exceed those observed in plasma.Levofloxacin is known to penetrate well into skin tissue, fluids (e.g. blisters), lung tissue, and prostatic tissue, amongst others. |
| Clearance | The average apparent total body clearance of levofloxacin ranges from 8.64-13.56 L/h, and its renal clearance ranges from 5.76-8.52 L/h.The relative similarity of these ranges indicates a small degree of non-renal clearance. |
Formulation & handling
- Suitable for both oral solid dosage forms and aqueous IV or ophthalmic solutions due to its small‑molecule nature and moderate aqueous solubility.
- Formulations should account for pH‑dependent solubility and potential precipitation; IV products typically require controlled pH and chelator management.
- Food has minimal impact on absorption, allowing flexible administration without specific fed‑state considerations.
Regulatory status
| Lifecycle | Most U.S. patent protection for the API has expired, with the final patent ending in 2022, indicating a mature lifecycle with established generic availability. With presence across Canada, the US, and the EU, the product is positioned in well-developed, competitive markets. |
|---|
| Markets | Canada, US, EU |
|---|
Supply Chain
| Supply chain summary | Levofloxacin was originally developed by a small group of originator firms, with later commercialization supported by a wide network of repackagers and distributors. Branded and generic presentations are established across the US, EU, and Canada, reflecting mature global market penetration. Key patents have expired, indicating that generic competition is already well‑established in major markets. |
|---|
Safety
| Toxicity | The LD<sub>50</sub> following oral administration in mice and rats is 1803 mg/kg and 1478 mg/kg, respectively. Levofloxacin exhibits low potential for acute toxicity - following a single high dose of levofloxacin in several different test animals (e.g. mice, rats, monkeys) observed symptoms included ataxia, ptosis, decreased motor activity, dyspnea, tremors, and convulsions.Treatment of acute overdosage should involve stomach emptying (e.g. with activated charcoal) and general supportive measures. Consider monitoring of the patient's ECG to ensure QTc values remain within range.Levofloxacin is not efficiently removed by dialysis (peritoneal or hemodialysis) and is therefore of little benefit in cases of overdose. |
|---|
- Acute toxicity is low to moderate
- Oral LD50 values are approximately 1800 mg/kg in mice and 1500 mg/kg in rats
- High-dose exposure in test animals produced neurologic and respiratory effects such as ataxia, decreased motor activity, dyspnea, tremors, and convulsions
US Drug Master File (USDMF)
A US Drug Master File (USDMF) is a confidential document submitted to the U.S. Food and Drug Administration (FDA) that provides detailed information about the manufacturing process of an Active Pharmaceutical Ingredient (API) or a finished pharmaceutical product. This document includes comprehensive details such as chemical properties, manufacturing facilities, production processes, packaging specifications, storage conditions, and more.
The USDMF ensures that proprietary information remains protected while allowing the FDA to review the data as part of drug approval processes. Unlike other types of DMFs used in different regions, the USDMF is specifically designed to meet the regulatory requirements set by the FDA, ensuring compliance with U.S. standards.
Levofloxacin is a type of Quinolones
Quinolones belong to a vital subcategory of pharmaceutical active pharmaceutical ingredients (APIs). They are a group of synthetic antibiotics that possess a broad-spectrum activity against various bacterial infections. This technical description will shed light on the key characteristics and applications of quinolones.
Quinolones exhibit potent bactericidal activity by targeting DNA gyrase and topoisomerase IV, which are essential enzymes for bacterial DNA replication and repair. This mechanism of action distinguishes quinolones from other classes of antibiotics, making them effective against both Gram-positive and Gram-negative bacteria.
The versatility of quinolones enables their application in the treatment of a wide range of infections, including respiratory tract infections, urinary tract infections, gastrointestinal infections, skin and soft tissue infections, and sexually transmitted diseases. Furthermore, they have proven efficacy against bacteria resistant to other antibiotics, making them indispensable in clinical practice.
Pharmaceutical companies utilize advanced manufacturing processes to synthesize quinolones with high purity and quality. Stringent quality control measures ensure the safety and efficacy of these APIs, complying with regulatory standards.
Quinolones have revolutionized the field of antibacterial therapy, providing healthcare professionals with potent tools to combat bacterial infections. However, it is crucial to utilize them judiciously to prevent the emergence of antibiotic resistance.
In conclusion, quinolones, as a subcategory of pharmaceutical APIs, possess remarkable antibacterial properties, making them invaluable in the treatment of various infections. Their broad-spectrum activity, mechanism of action, and effectiveness against resistant bacteria make quinolones a crucial component of modern healthcare.
Levofloxacin (Quinolones), classified under Anti-infective Agents
Anti-infective agents are a vital category of pharmaceutical active pharmaceutical ingredients (APIs) used in the treatment of various infectious diseases. These agents play a crucial role in combating bacterial, viral, fungal, and parasitic infections. The demand for effective anti-infective APIs has grown significantly due to the increasing prevalence of drug-resistant microorganisms.
Anti-infective APIs encompass a wide range of substances, including antibiotics, antivirals, antifungals, and antiparasitics. Antibiotics are particularly important in fighting bacterial infections and are further categorized into different classes based on their mode of action and target bacteria. Antivirals are designed to inhibit viral replication and are essential in the treatment of viral infections such as influenza and HIV. Antifungals combat fungal infections, while antiparasitics are used to eliminate parasites that cause diseases like malaria and helminthiasis.
The development and production of high-quality anti-infective APIs require stringent manufacturing processes and adherence to regulatory standards. Pharmaceutical companies invest heavily in research and development to discover new and more effective anti-infective agents. Additionally, ensuring the safety, efficacy, and stability of these APIs is of utmost importance.
The global market for anti-infective APIs is driven by factors such as the rising incidence of infectious diseases, the emergence of new and drug-resistant pathogens, and the growing demand for improved healthcare infrastructure. Continuous advancements in pharmaceutical technology and the development of innovative drug delivery systems further contribute to the expansion of this market.
In conclusion, anti-infective agents are a critical category of pharmaceutical APIs that play a pivotal role in treating infectious diseases. Their effectiveness in combating various types of infections makes them essential components in the arsenal of modern medicine.
Levofloxacin API manufacturers & distributors
Compare qualified Levofloxacin API suppliers worldwide. We currently have 31 companies offering Levofloxacin API, with manufacturing taking place in 8 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.
| Supplier | Type | Country | Product origin | Certifications | Portfolio |
|---|---|---|---|---|---|
| Alfresa Fine Chemical | Producer | Japan | Japan | CoA, JDMF | 2 products |
| Aurora Industry Co., Ltd | Distributor | China | China | BSE/TSE, CEP, CoA, GMP, ISO9001, MSDS, WC | 250 products |
| Chemi S.p.A. | Producer | Italy | Brazil | CoA, JDMF | 18 products |
| Chemo Iberica | Producer | Spain | Spain | CoA, USDMF | 12 products |
| Cipla | Producer | India | India | CoA, GMP, USDMF, WC | 164 products |
| Daiichi Sankyo | Producer | Japan | Japan | CoA, USDMF | 9 products |
| Dongbang FTL | Producer | South Korea | South Korea | CoA, JDMF, KDMF | 13 products |
| HEC Pharm | Producer | Germany | Unknown | CoA, USDMF | 31 products |
| Hetero Drugs | Producer | India | India | CoA, GMP, USDMF, WC | 98 products |
| Humble Healthcaare | Producer | India | India | CoA | 30 products |
| Ildong Pharmaceutical | Producer | South Korea | South Korea | CoA, JDMF | 4 products |
| Iwaki Seiyaku | Producer | Japan | Japan | CoA, JDMF | 21 products |
| Jiangxi Chenyang | Producer | China | China | CoA | 5 products |
| K. Sevantilal & Co. | Producer | India | India | CoA | 8 products |
| Kolon Life Science | Producer | South Korea | South Korea | CoA, JDMF | 32 products |
| LGM Pharma | Distributor | United States | World | BSE/TSE, CEP, CoA, GMP, MSDS, USDMF | 441 products |
| Lupin | Producer | India | India | CoA, GMP, USDMF, WC | 155 products |
| MSN Life Sciences | Producer | India | India | CoA, USDMF | 46 products |
| Mylan | Producer | India | India | CoA, GMP, JDMF, USDMF, WC | 201 products |
| Quimica Sintetica | Producer | Spain | Unknown | CoA, USDMF | 51 products |
| Ranbaxy Laboratories | Producer | India | India | CoA, JDMF | 7 products |
| Shangyu Jingxin | Producer | China | China | CoA, JDMF, WC | 4 products |
| Shaoxing Hantai Pharma | Distributor | China | China | CoA | 162 products |
| Sun Pharma | Producer | India | India | CoA, GMP, WC | 219 products |
| TURTLE PHARMA | Producer | India | India | CoA, USDMF | 3 products |
| Unnati Pharmaceuticals Pv... | Distributor | India | India | CoA | 70 products |
| Yuhan Chemical | Producer | South Korea | South Korea | CoA, JDMF | 8 products |
| Zhejiang East Asia Pharma... | Producer | China | China | CoA, JDMF | 4 products |
| Zhejiang East-Asia Pharma | Producer | China | China | CoA, JDMF | 7 products |
| Zhejiang Starry | Producer | China | China | CoA, JDMF, WC | 3 products |
| Zhejiang Tiantai | Producer | China | China | CoA, WC | 7 products |
When sending a request, specify which Levofloxacin API quality you need: for example EP (Ph. Eur.), USP, JP, BP, or another pharmacopoeial standard, as well as the required grade (base, salt, micronised, specific purity, etc.).
Use the list above to find high-quality Levofloxacin API suppliers. For example, you can select GMP, FDA or ISO certified suppliers. Visit our help page to learn more about sourcing APIs via Pharmaoffer.
Frequently asked questions about Levofloxacin API
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